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NCT Number: NCT07315373

Optimal Dose of Zanubrutinib to Treat Adult Immune Thrombocytopenia

The goal of this clinical trial is to find the best dose of zanubrutinib when used together with high-dose dexamethasone for adults who are newly diagnosed with primary immune thrombocytopenia (ITP), and to learn how safe and effective this combination treatment is.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed newly-diagnosed, treatment-naive ITP;
  • Platelet counts <30×10^9/L ;
  • Platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
  • Willing and able to sign written informed consent.

Exclusion criteria

  • Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
  • Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
  • Current HIV infection or hepatitis B virus or hepatitis C virus infections;
  • Active infection;
  • Maligancy;
  • Severe medical condition (lung, hepatic or renal disorder) other than ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
  • Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
  • Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
  • Patients who are deemed unsuitable for the study by the investigator.

Treatment and study plan

Zanubrutinib 80mg/d

Drug

Zanubrutinib: 80 mg taken orally once daily for 26 weeks

High dose dexamethasone

Drug

Dexamethasone: 40 mg taken orally once daily for 4 consecutive days at the beginning of treatment. A second identical 4-day course may be repeated after 2 weeks if an adequate initial platelet response is not achieved.

Zanubrutinib 160mg/d

Drug

Zanubrutinib: 160 mg taken orally once daily for 26 weeks

Zanubrutinib 240mg/d

Drug

Zanubrutinib: 240 mg taken orally once daily for 26 weeks

Primary outcomes

  1. Sustained response

    Time frame: 26 weeks

    The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 26-week follow-up.

Secondary outcomes

  1. Initial Response (R)

    Time frame: day 14

    Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.

  2. Initial complete response (CR)

    Time frame: day 14

    Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.

  3. Time to response

    Time frame: 6 month

    The time from starting treatment to time of achievement of CR or R

  4. Duration of response (DOR)

    Time frame: 26 weeks

    Duration of response at 26-week follow up

  5. Bleeding events

    Time frame: 26 weeks

    Number of patients with bleeding

  6. Adverse events

    Time frame: 26 weeks

    Number of patients with adverse events

  7. Loss of response

    Time frame: 26 weeks

    Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)

  8. Health related quality of life

    Time frame: baseline and 26 weeks

    Health-related quality of life using the Immune Thrombocytopenic Purpura-Patient Assessment Questionnaire (ITP-PAQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Qiusha Huang, MD

CONTACT

[email protected]

8688324577

Xiaohui Zhang, MD

CONTACT

[email protected]

8688324577

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

The FIND Study: A Dose-finding Study to Identify the Optimal Dose of Zanubrutinib in Adults With Immune Thrombocytopenia

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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